The newsletter provides a summary of recent news or key updates in the field of medical writing and relevant for our business activities.
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The European Commission, Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) have launched an initiative to transform how clinical trials are initiated, designed, and run, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. The ten priority actions of ACT EU for 2022/2023 include enabling innovative trial methods, establishing a multi-stakeholder platform and supporting the modernisation of good clinical practice. The document can be accessed at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/accelerating-clinical-trials-eu-act-eu-delivering-eu-clinical-trials-transformation-initiative_en.pdf
clinicaltrials.gov have posted new and updated FAQs to clarify the ‘Deadline for Submitting Good Cause Extension Requests for Delayed Submission of Results Information’. Responsible parties may only submit good cause extension requests for delayed submission of results information prior to the date (i.e. the day before) that results information would otherwise be due.
FDA has issued a draft guidance ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’. The draft guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products.
The FDA released the final guidance for industry on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies. FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. This guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies.
The FDA also released final guidance for industry on Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. The guidance outlines best practices for selecting, developing, modifying, or adapting a PRO instrument for use in medical device evaluation.
Sources: EMA, FDA and EMWA websites